Department of Uro-Neurology, UCL Institute of Neurology and The National Hospital for Neurology and Neurosurgery, London, UK.
Curr Urol Rep. 2013 Jun;14(3):227-34. doi: 10.1007/s11934-013-0326-9.
Botulinum toxin-A (BTX-A) is well established in the management of various aspects of lower urinary tract dysfunction (LUTD). One formulation, OnabotulinumtoxinA has recently been licensed in many parts of the world for use in neurogenic detrusor overactivity (NDO), and in the US for idiopathic overactive bladder (OAB), in patient's refractory to antimuscarinics. This review article looks at recent clinical publications that examine the use of BTX-A for the treatment of LUTD with a focus on OAB, detrusor overactivity (DO), benign prostatic hyperplasia (BPH) and Painful bladder syndrome / interstitial cystitis (PBS / IC). A literature review was conducted using the PubMed database and studies that were published within the time frame of January 2011 to present were included. Large randomised placebo controlled trials and a pooled analysis of patients with multiple sclerosis / spinal cord injury and NDO has suggested that BTX-A improved urinary incontinence (UI) episodes, urodynamic parameters and QoL in these patients. 200 U of OnabotulinumtoxinA appeared equivalent to 300 U. In patients with OAB, lower doses of 100 U OnabotulinumtoxinA, appear efficacious and with an acceptable adverse event profile. In one large phase III trial, de novo clean intermittent catheterisation rates were 6.1 %. Repeated injections in DO appear efficacious. Results from BPH studies are mixed, and the largest randomised study in this setting has shown significant improvements in a number of parameters for a variety of OnabotulinumtoxinA doses, but none of the doses were statistically better than placebo. Few studies have been conducted in PBS / IC and larger scale randomised placebo controlled trials are required to validate its use in this setting.
肉毒杆菌毒素 A（BTX-A）已广泛应用于下尿路功能障碍（LUTD）的各个方面的治疗。最近，一种制剂奥氮平毒素 A 在世界许多地方被批准用于治疗神经源性逼尿肌过度活动（NDO），并在美国用于对抗毒蕈碱药物无反应的特发性逼尿肌过度活动症（OAB）。本文综述了最近的临床文献，探讨了 BTX-A 治疗 LUTD 的应用，重点关注 OAB、逼尿肌过度活动（DO）、良性前列腺增生（BPH）和疼痛性膀胱综合征/间质性膀胱炎（PBS/IC）。采用 PubMed 数据库进行文献回顾，纳入 2011 年 1 月至目前发表的研究。大型随机安慰剂对照试验和对多发性硬化症/脊髓损伤和 NDO 患者的汇总分析表明，BTX-A 改善了这些患者的尿失禁（UI）发作、尿动力学参数和生活质量。200U 的奥氮平毒素 A 与 300U 相当。在 OAB 患者中，100U 奥氮平毒素 A 的低剂量似乎有效，且不良反应可接受。在一项大型 III 期试验中，新出现的清洁间歇性导尿率为 6.1%。DO 的重复注射有效。BPH 研究的结果参差不齐，在该环境下进行的最大随机研究显示，各种奥氮平毒素 A 剂量在许多参数方面均有显著改善，但没有一种剂量在统计学上优于安慰剂。在 PBS/IC 中进行的研究较少，需要进行更大规模的随机安慰剂对照试验来验证其在该环境下的应用。
